CompletedPhase 1

A Study to Evaluate the Pharmacokinetics and Safety of BEY2153 in Healthy Participants

South Korea88 participantsStarted 2020-08-27

Plain-language summary

This is a first in human Phase 1 study to evaluate the safety, tolerability and pharmacokinetics with healthy young and elderly adult male volunteers after receiving single and multiple ascending dose of BEY2153.

Who can participate

Age range19 Years – 80 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Young adult: A healthy Korean male aged 19 to 45 (inclusive) years at the time of screening Elderly adult: A healthy Korean male aged over 65 (inclusive) years at the time of screening"
✓. Subjects weighing between 55 kg and 90 kg with BMI between 18.0 and 27.0 kg/m2 (inclusive) at screening.
✓. Subjects who have listened to the detailed description of this clinical trial and have fully understood, and who have agreed in writing to voluntarily participate and observe the precautions prior to receiving any of the screening procedures
✓. Subjects who is eligible for this clinical trial by the investigator's judgement with laboratory test results and physical-examination findings and etc.

Exclusion criteria

✕. Young adult / Elderly adult: Subjects with evidence or a history of clinically significant hepatic, renal, neurologic, immunologic, pulmonary, endocrine or hematological, neoplastic, cardiovascular, psychiatric diseases (mood disorder, obsessive-compulsive disorder etc.).
✕. Subjects with evidence or a history of gastrointestinal disease or with history of gastrointestinal surgery that may affect assessment of safety, PK characteristics of study drug.
✕. Subjects who showed significant abnormalities at neurologic examination at screening visit.
✕. Subjects who showed any abnormalities at vital signs
✕. Subjects who showed any abnormalities at blood test
✕. Subjects with serum AST (SGOT) or ALT (SGPT) level or total bilirubin exceed 1.5 times the upper limit of the normal range at screening
✕. Subjects who showed any abnormalities at ECG subsection
✕. Subjects who are hypersensitive to drugs, or who have clinically significant hypersensitivity reactions history.

What they're measuring

Maximum observed plasma concentration (Cmax)

Timeframe: Day 1 to Day 9

Area Under the Curve (AUC)

Timeframe: Day 1 to Day 9

Apparent terminal elimination half-life (t1/2)

Timeframe: Day 1 to Day 9

Apparent clearance (CL/F)

Timeframe: Day 1 to Day 9

Apparent volume of distribution (Vz/F)

Timeframe: Day 1 to Day 9

Trial details

NCT IDNCT04476303

SponsorBeyondBio Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-11-23

View on ClinicalTrials.gov More Alzheimer's Disease trials

Who can participate

Age range19 Years – 80 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Young adult: A healthy Korean male aged 19 to 45 (inclusive) years at the time of screening Elderly adult: A healthy Korean male aged over 65 (inclusive) years at the time of screening"
✓. Subjects weighing between 55 kg and 90 kg with BMI between 18.0 and 27.0 kg/m2 (inclusive) at screening.
✓. Subjects who have listened to the detailed description of this clinical trial and have fully understood, and who have agreed in writing to voluntarily participate and observe the precautions prior to receiving any of the screening procedures
✓. Subjects who is eligible for this clinical trial by the investigator's judgement with laboratory test results and physical-examination findings and etc.

Exclusion criteria

✕. Young adult / Elderly adult: Subjects with evidence or a history of clinically significant hepatic, renal, neurologic, immunologic, pulmonary, endocrine or hematological, neoplastic, cardiovascular, psychiatric diseases (mood disorder, obsessive-compulsive disorder etc.).
✕. Subjects with evidence or a history of gastrointestinal disease or with history of gastrointestinal surgery that may affect assessment of safety, PK characteristics of study drug.
✕. Subjects who showed significant abnormalities at neurologic examination at screening visit.
✕. Subjects who showed any abnormalities at vital signs
✕. Subjects who showed any abnormalities at blood test
✕. Subjects with serum AST (SGOT) or ALT (SGPT) level or total bilirubin exceed 1.5 times the upper limit of the normal range at screening
✕. Subjects who showed any abnormalities at ECG subsection
✕. Subjects who are hypersensitive to drugs, or who have clinically significant hypersensitivity reactions history.

What they're measuring

Maximum observed plasma concentration (Cmax)

Timeframe: Day 1 to Day 9

Area Under the Curve (AUC)

Timeframe: Day 1 to Day 9

Apparent terminal elimination half-life (t1/2)

Timeframe: Day 1 to Day 9

Apparent clearance (CL/F)

Timeframe: Day 1 to Day 9

Apparent volume of distribution (Vz/F)

Timeframe: Day 1 to Day 9